Senior Regulatory Affairs Leader, Oncology Submissions

Regulatory Jobs; San Diego (CA); Vor Ort; USD 165.000 - 175.000; Vollzeit

Zusammenfassung

ORIC Pharmaceuticals is seeking an experienced Regulatory Affairs professional to advance oncology programs. You will coordinate INDs/CTAs, prepare submissions, and provide regulatory guidance across US, EU, and other regions, collaborating with CMC, nonclinical, and clinical teams.

The ideal candidate has extensive IND/CTA experience, strong writing skills, and excellent project management. You will manage submission timelines, maintain health authority archives, and stay current with FDA/ICH

Qualifikationen

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• 12 years’ experience with a Bachelor’s degree or 8 years with a Master’s; 5 years with a PhD/ PharmD.
• Hands-on experience with U.S. IND submissions, EU CTIS, and outside-US CTAs.
• Experience coordinating regulatory submissions and health authority interactions.

Aufgaben

• Coordinate IND/CTA submissions to US, EU, and other regions.
• Prepare and deliver high-quality regulatory submissions in compliance with regs.
• Provide regulatory guidance on US/EU CTIS and country-specific CTA processes.
• Create, review, and archive complex submissions with internal/CRO teams.
• Develop and track regulatory submission timelines.
• Collaborate across regulatory, quality, CMC, nonclinical, and clinical teams.

Kenntnisse

Regulatory submissions

IND submissions

Regulatory strategy

Cross-functional

Project management

Writing/editing

Attention to detail

Regulatory intelligence

Ausbildung

Bachelor’s degree in science

Advanced degree preferred

Tools

Veeva RIM

MS Office

Jobbeschreibung

ORIC Pharmaceuticals is seeking an experienced Regulatory Affairs professional to advance oncology programs. You will coordinate INDs/CTAs, prepare submissions, and provide regulatory guidance across US, EU, and other regions, collaborating with CMC, nonclinical, and clinical teams.

The ideal candidate has extensive IND/CTA experience, strong writing skills, and excellent project management. You will manage submission timelines, maintain health authority archives, and stay current with FDA/ICH